Catheter assembly clamp with acoustic sensor

Abstract

To provide a method for monitoring a flow of fluid flowing through a catheter assembly.SOLUTION: A method is for monitoring a flow of fluid passing a catheter assembly and includes: a step which provides a clamp disposed to fasten an extension tube of the catheter assembly, the clamp provided with an acoustic sensor arranged to detect fluid flowing through the extension tube and the clamp and acoustic sensor disposed outside the extension tube; and a step which detects a flow of fluid flowing through the extension tube via the acoustic sensor.SELECTED DRAWING: Figure 1A

Description

Technical Field

[0001] Catheters are commonly used for a variety of infusion therapies. For example, a catheter may be used to infuse a patient with fluids such as normal saline aqueous solution, a variety of pharmaceuticals, and parenteral nutrients. A catheter may be used to draw blood from a patient.

Background Art

[0002] A common type of catheter is an over-the-needle peripheral intravenous catheter ("PIVC"), a peripherally inserted central catheter ("PICC"), or a midline catheter. As its name implies, an over-the-needle catheter can be mounted on an introducer needle having a sharp distal tip. The sharp distal tip may be used to pierce the skin and the patient's blood vessel. Insertion of the catheter into the blood vessel may follow piercing of the blood vessel by the needle. The needle and catheter are generally inserted through the skin at a shallow angle into the patient's vascular system with the bevel of the needle facing away from the patient's skin. When placement of the introducer needle in the vascular system is confirmed, the physician may temporarily occlude the flow in the vascular system, withdraw the introducer needle, and leave the catheter in place within the blood vessel for subsequent blood sampling and / or fluid infusion.

[0003] For example, a catheter may become unstable or yield due to occlusion of the catheter over time. In response to the catheter becoming occluded, the catheter may need to be removed and replaced with a new catheter. Catheter occlusion may be thrombotic, resulting from formation of a thrombus within or around the distal end of the catheter. Catheter occlusion may be non-thrombotic, resulting from precipitates, mechanical occlusion, and other factors. Further, catheter occlusion can cause catheter infection, acute pulmonary embolism, post-thrombotic syndrome, and other negative health outcomes. The physician may periodically flush the catheter to prevent occlusion and extend the catheter's indwelling period.

[0004] The subject matter claimed herein is not limited to embodiments that resolve any disadvantage or that operate only in environments such as those described above. Rather, this background is provided merely to illustrate one exemplary area of ​​technology in which several embodiments described herein may be implemented. [Overview of the Initiative]

[0005] This disclosure relates, in general, to vascular access systems and related apparatus and methods. In some embodiments, a method for managing the cleaning of a catheter assembly may include providing a clamp for the extension tube of the catheter assembly. In some embodiments, the clamp may be equipped with an acoustic sensor which may be positioned to detect whether the clamp is open or whether fluid is flowing through the extension tube of the catheter assembly. In some embodiments, the acoustic sensor may be positioned to detect whether the clamp is closed or whether fluid is not flowing through the extension tube of the catheter assembly.

[0006] In some embodiments, the method may include activating a timer in response to an acoustic sensor detecting that a clamp is closed. In some embodiments, the method may include providing an alert in response to the timer reaching a predetermined length of time. In some embodiments, the alert may instruct a physician that the catheter assembly be opened and cleaned to prevent occlusion of the catheter assembly.

[0007] In some embodiments, providing an alert may involve sending an alert signal over a network to a monitoring device so that a physician can monitor the device. In some embodiments, the alert signal may instruct the monitoring device to provide an alert. In some embodiments, the alert may include sound, tactile vibration, or a visual cue. In some embodiments, the visual cue may include a change in the state of a light. In some embodiments, in response to an acoustic sensor detecting that the clamp is closed, the display may be provided in the patient's electronic health record.

[0008] In some embodiments, an acoustic sensor may be positioned to detect that the clamp is open. In some embodiments, in response to the acoustic sensor detecting that the clamp is open for another predetermined period of time, the timer may be stopped and / or reset. In some embodiments, in response to the acoustic sensor detecting that the clamp is open for another predetermined period of time, another alert signal may be sent to the monitoring device over the network to stop the alert or provide another alert. In some embodiments, in response to the acoustic sensor detecting that the clamp is open for another predetermined period of time, another display may be provided on the patient's electronic health record.

[0009] In some embodiments, another acoustic sensor may be provided. In some embodiments, the acoustic sensor and the other acoustic sensor may provide a robust determination of whether fluid is flowing through the extension tube and whether the clamp is open or closed. In some embodiments, the acoustic sensor may be located distal to the other acoustic sensor. In some embodiments, the direction of fluid flow in the extension tube may be determined in response to the acoustic sensor detecting fluid flow through the extension tube, either before or after the other acoustic sensor detects fluid flow through the extension tube. In some embodiments, the timer may be stopped and / or reset in response to the other acoustic sensor detecting that the clamp is open and fluid is flowing through the extension tube of the catheter assembly.

[0010] The objectives and effects of the embodiments will be realized and achieved at least by the elements, features, and combinations specifically indicated in the claims. It should be understood that both the above general description and the following detailed description are illustrative and descriptive, and do not limit the invention as claimed. [Brief explanation of the drawing]

[0011] Exemplary embodiments will be described and explained with additional specificities and details through the use of the attached drawings.

[0012] [Figure 1A] This is a top perspective view of an exemplary catheter system according to several embodiments. [Figure 1B] This is an exemplary top perspective view of a clamp showing the clamp in an open position according to several embodiments. [Figure 1C] Figure 1B is an upper perspective view of the clamp in a closed position according to several embodiments. [Figure 2A] This is a top perspective view of an exemplary physician monitoring device according to several embodiments. [Figure 2B]An exemplary electronic health record, which may be shown on the display screen of an exemplary physician monitoring device according to several embodiments. [Figure 3] This is a block diagram of an exemplary cleaning management system according to several embodiments. [Figure 4A] This is a top perspective view showing another exemplary clamp that may be used in the catheter system of Figure 1A, showing the clamp in the open position. [Figure 4B] Figure 4A is an upper perspective view showing the clamp in the closed position. [Figure 5A] This is a graph of an example waveform generated by an acoustic sensor. [Figure 5B] This is a graph of example waveforms generated by two acoustic sensors. [Modes for carrying out the invention]

[0013] Referring now to Figure 1A, an exemplary catheter system 14 according to several embodiments is shown. In some embodiments, the catheter system 14 may include a catheter assembly 16. In some embodiments, the catheter assembly 16 may include a catheter adapter 18 and a catheter 20 extending distally from the catheter adapter 18. In some embodiments, the catheter adapter 18 may include a side port 22 that is in fluid communication with the lumen of the catheter adapter 18. In some embodiments, the catheter adapter 18 may include a proximal end 23, a distal end 24, and a lumen extending between them. In some embodiments, the catheter 20 may include a PIVC.

[0014] In some embodiments, the catheter assembly 16 may be movably connected to the needle assembly, which may comprise a needle hub 26 and an introduction needle 28. In some embodiments, the introduction needle 28 may have a sharp distal end. In some embodiments, the proximal end of the introduction needle 28 may be fixed within the needle hub 26.

[0015] In some embodiments, for example as shown in Figure 1A, when the catheter assembly 16 is in a ready insertion position for insertion into the patient's blood vessel, the introduction needle 28 may extend through the catheter 20. In some embodiments, in response to the introduction needle 28 being inserted into the patient's blood vessel, a flashback of blood may flow through the sharp distal end 30 of the introduction needle 28 and be visible to the physician between the introduction needle 28 and the catheter 20 and / or elsewhere in the catheter assembly 16.

[0016] In some embodiments, the needle assembly may be removed from the catheter assembly 16 in response to confirmation via a flashback of blood that the catheter 20 is positioned in the patient's blood vessel. In some embodiments, for example as shown in Figure 1A, when the needle assembly is connected to the catheter assembly 16, the introduction needle 28 of the needle assembly may extend through a septum located within the lumen of the catheter adapter 18.

[0017] In some embodiments, the catheter system 14 may include a catheter line 32 which may include an extension tube 34 and a clamp 36 through which the extension tube 34 can extend. In some embodiments, the distal end of the extension tube 34 may be integrated with the catheter adapter 18, for example, as shown in Figure 1A. For example, the extension tube 34 may be integrated with the side port 24 of the catheter adapter 18. In some embodiments, the extension tube 34 may be movably connected to the catheter adapter 18. In some embodiments, the clamp 36 may selectively close the extension tube 34 to prevent blood or another fluid from flowing through the extension tube 34.

[0018] In some embodiments, the adapter 38 may be connected to the proximal end of the extension tube 34. In some embodiments, the adapter 38 may comprise a Y-adapter or another suitable connector. In some embodiments, the needleless connector 40 may be connected to the adapter 38. In some embodiments, the adapter 38 and / or the needleless connector 40 may be used to connect the catheter 20 to a medical device for fluid administration or blood sampling. The medical device may comprise an infusion bag, a syringe, or any other suitable medical device.

[0019] In some embodiments, the catheter system 14 may comprise any suitable catheter assembly 16, and the clamp 36 may be connected to any suitable extension tube. In some embodiments, the extension tube 34 may extend from the proximal end 23 of the catheter adapter 18. In some embodiments, the clamp 36 may be disposed on an IV line, which may extend between an IV bag and the catheter assembly 16. In some embodiments, the catheter assembly 16 may comprise a PIVC, a PICC, or a midline catheter. In some embodiments, a peripherally inserted central catheter (''PICC'') assembly may be connected to one or more pigtail extension tubes.

[0020] In some embodiments, the extension set may be arranged to be connected directly or indirectly to the catheter assembly 16. In some embodiments, the extension set may comprise an IV line, the extension tube 34, or any other extension tube in fluid communication with the catheter assembly 16. In some embodiments, the extension set may comprise a clamp 36.

[0021] Referring now to FIG. 1B, in response to when the clamp 36 is open, fluid may flow through the extension tube 34 and through the catheter assembly 16. For example, the fluid may be injected into the patient via a medical device coupled to the adapter 38, or blood may be drawn from the patient into a blood collection device coupled to the adapter 38. In some embodiments, the clamp 38 may include a first acoustic sensor 42a and / or a second acoustic sensor 42b (which are collectively referred to herein as "acoustic sensors 42"). In some embodiments, each of the acoustic sensors 42 may be arranged to detect fluid flowing through the extension tube 34 or the clamp 36 being open. In some embodiments, each of the acoustic sensors 42 may be arranged to detect fluid not flowing through the extension tube 34 or the clamp 36 being closed. In some embodiments, the first acoustic sensor 42a and / or the second acoustic sensor 42b may include one or more microphones.

[0022] In some embodiments, the first acoustic sensor 42a and the second acoustic sensor 42b may provide a robust determination as to whether fluid is flowing through the extension tube 34 and whether the clamp 36 is open or closed. In some embodiments, the first acoustic sensor 42a may be disposed at the distal end of the second acoustic sensor 42b. In some embodiments, the direction of fluid flow within the extension tube 34 may be determined in response to the first acoustic sensor 42a detecting fluid flow through the extension tube 34 before or after the other acoustic sensor 42b detects fluid flow through the extension tube 34. In some embodiments, the direction of fluid flow may be determined to be proximal in response to the first acoustic sensor 42a detecting fluid flow through the extension tube 34 before the second acoustic sensor 42b detects fluid flow through the extension tube 34. In some embodiments, the direction of fluid flow may be determined to be distal in response to the second acoustic sensor 42b detecting fluid flow through the extension tube 34 before the first acoustic sensor 42a detects fluid flow through the extension tube 34.

[0023] In some embodiments, the acoustic sensor 42 may be electrically connected to the circuit board 43 and the charger 44. In some embodiments, the positions of the circuit board 43 and the charger 44 may vary. In some embodiments, the circuit board 43 may include a transmitting unit.

[0024] Referring now to Figure 1C, when the clamp 36 is closed, the fluid may be prevented from flowing through the extension tube 34. In some embodiments, when the clamp 36 is closed, substantially all of the fluid may be prevented from flowing through the extension tube 34. In some embodiments, the clamp 36 may be a clamping clamp that tightens the extension tube 34 in response to the clamp 36 moving to the closed position.

[0025] In some embodiments, the clamp 36 may be any clamp connected to an extension tube, such as an extension tube 34. In some embodiments, an exemplary clamp 36 is described in U.S. Patent Application No. 15 / 286,248, filed on October 5, 2016, with the title “A clamping device,” which is incorporated herein by reference. In some embodiments, the extension tube 34 may extend through the clamp 36. In some embodiments, the clamp 36 may include an arm 47, which may have a projection that contacts and clamps the extension tube 34. In some embodiments, the clamp 36 may include any suitable clamp, and the acoustic sensor 42 may include any suitable acoustic sensor. In some embodiments, the acoustic sensor 42 may be positioned in a variety of locations.

[0026] In some embodiments, the acoustic sensor 42 may be embedded in the clamp 36. In these, and in other embodiments, one or more acoustic sensors 42 may be in contact with the extension tube 34. In some embodiments, one or more acoustic sensors 42 may be spaced apart from the extension tube 34. In some embodiments, the first acoustic sensor 42a may be positioned distal to the second acoustic sensor 42b.

[0027] In some embodiments, a portion of the acoustic sensor 42 may be modified. In some embodiments, when the clamp 36 is in an open and / or closed position, the acoustic sensor 42 may be positioned on the clamping surface of the clamp 36 that contacts the extension tube 34. In some embodiments, the clamping surface may generally be flat or curved. In some embodiments, the acoustic sensor 42 may be positioned on a non-clamping surface. In some embodiments, the acoustic sensor 42 may be positioned on the opposite side of the extension tube 34. In some embodiments, the acoustic sensor 42 may be positioned on the same side of the extension tube 34.

[0028] In some embodiments, the clamp 36 may provide an alert that may include an audible, tactile vibration, or visual cue. In some embodiments, the visual cue may include a change in the state of a light. Figure 1B-1C shows an exemplary light 48 according to some embodiments. In some embodiments, the state of the light 48 may change in response to the clamp being closed for a predetermined period of time. For example, in response to the clamp being closed for a predetermined period of time, the light 48 may be turned on or change color. As another specific example, in response to the clamp 36 being closed for a predetermined period of time, the light 38 may flash or change flashing speed.

[0029] In some embodiments, a predetermined length of time may correspond to a time prior to the time medically recommended for cleaning the catheter assembly 16. In these embodiments, the alert may include a warning that indicates to the physician that the time medically recommended for cleaning the catheter assembly 16 is approaching. In some embodiments, the time medically recommended for cleaning the catheter assembly 16 may be between approximately 6 and 8 hours since the last cleaning of the catheter assembly 16.

[0030] In some embodiments, a predetermined length of time may correspond to a medically recommended time for rinsing the catheter assembly 16. In some embodiments, a first alert may be provided by the clamp 36 in response to the approaching medically recommended time for rinsing the catheter assembly 16 (e.g., 30 minutes, 10 minutes, or 5 minutes), and a second alert may be provided by the clamp 36 in response to the arrival of the medically recommended time for rinsing the catheter assembly 16. In some embodiments, the first alert may be provided by a yellow or orange light, and the second alert may be provided by a red light.

[0031] In some embodiments, the light 48 may be positioned in various locations on the clamp 36 and may be visible to the doctor. In some embodiments, the clamp 36 may have multiple lights 48. In some embodiments, the size of the light 48 may vary.

[0032] Referring now to Figure 2A, exemplary physician monitoring devices 46 are shown according to several embodiments. Specific examples of physician monitoring devices 46 may include a computer device, mobile phone, smartphone, tablet computer, laptop computer, desktop computer, medical device, or a coupling device (e.g., a smartphone, smart glasses, or any other coupling device). In some embodiments, in addition to or as a substitute for the clamp 36, the physician monitoring device 46 may provide alerts.

[0033] In some embodiments, the physician monitoring device may include a display screen 50 which may provide alerts. In some embodiments, the alerts may include a phrase such as "Flush Due". In some embodiments, the alerts may include a visual cue on the display screen 50, such as a portion of the display screen 50 that lights up or changes color. In some embodiments, a portion of the display screen 50 may flash or change flashing speed to provide an alert. In some embodiments, the physician monitoring device 46 may include a light 48, as described with respect to Figure 1C, for example.

[0034] Referring now to Figure 2B, an exemplary electronic health record 52, shown on the display screen 50 of the physician monitoring device 46, is shown according to several embodiments. In some embodiments, a display is provided on the display screen 50 in response to opening and / or closing the clamp 36. In some embodiments, a display may be provided on the display screen 50 in response to opening the clamp 36 for a specific predetermined length of time and / or closing the clamp 36 for a specific predetermined length of time.

[0035] In some embodiments, the display may comprise one or more of the following: date and time 56, current state 58, and length of time 60. In some embodiments, length of time 60 may include the time when the clamp 36 was closed. In some embodiments, current state 58 may include "open" and may be adjacent to date and time 56, indicating to the physician the date and time when the clamp 36 was open. In some embodiments, current state 58 may include "closed" and may be adjacent to date and time 56, indicating to the physician the date and time when the clamp 36 was closed.

[0036] Figure 3 is a block diagram of an exemplary cleaning management system (FM system) 62 arranged according to at least one embodiment described herein. In some embodiments, the FM system 62 may include a clamp 63. In some embodiments, the clamp 63 may be the clamp 63 described with respect to Figure 1 or the clamp 90 described with respect to Figure 4, or correspond to them. In some embodiments, the clamp 63 may include a calculation system 64.

[0037] In some embodiments, the arithmetic system 64 may include a processor 66, memory 68, data storage 70, and a communication unit 72. In some embodiments, the processor 66, memory 68, data storage 70, and communication unit 72 may be communicatively connected by a bus 74. The bus 74 may include, but is not limited to, a Controller Area Network (CAN) bus, a memory bus, a storage interface bus, a bus / interface controller, an interface bus, or any combination thereof. In some embodiments, the processor 66 may include a timer 75. In some embodiments, the timer 75 may be another component linked to the processor 66.

[0038] In general, the processor 66 may be a preferred, special-purpose or general-purpose computer, computer entity, or processor device equipped with a variety of computer hardware and software modules, and may be configured to execute instructions stored on an applicable computer-readable storage medium. For example, the processor 66 may comprise a microprocessor, microcontroller, digital signal processor (DSP), application-specific IC (ASIC), field-programmable gate array (FPGA), or other digital or analog circuitry configured to decode and / or execute program instructions and / or process data. Although Figure 3 shows a single processor, the processor 66 may comprise a number of processors configured to perform many operations, either individually or as a group, as described in this disclosure. Furthermore, one or more processors 66 may reside on one or more different electronic devices.

[0039] In some embodiments, the processor 66 may decode and / or execute program instructions and / or process data stored in memory 68, data storage 70, or memory 68 and data storage 70. In some embodiments, the processor 66 may retrieve program instructions from data storage 70 and load them into memory 68. In some embodiments, after the program instructions have been loaded into memory 68, the processor 66 may execute the program instructions.

[0040] For example, in some embodiments, the cleaning module 76 may be included in the data storage 70 as a program instruction. In some embodiments, the cleaning module 76 may be configured to manage the cleaning of the catheter line 32 and the catheter assembly 16. In some embodiments, the cleaning module 76 may be configured to monitor the flow of fluid through the catheter assembly 16. The processor 66 may retrieve the program instruction for the cleaning module 76 from the data storage 70 and load the program instruction for the cleaning module 76 into memory 68. After the program instruction for the cleaning module 76 is loaded into memory 68, the processor 66 may execute the program instruction, and the arithmetic system 64 may perform operations associated with the cleaning module 76 as indicated by the instruction.

[0041] The memory 68 and data storage 70 may include a computer-decipherable storage medium for holding or having computer-executable instructions or data structures stored therein. Such a computer-decipherable storage medium may include any available medium accessible by a general-purpose or special-purpose computer, such as the processor 66. For example, but not limited to, such a computer-decipherable storage medium may include tangible or non-temporary computer-decipherable storage medium, including RAM, ROM, EEPROM, CD-ROM or other optical disk storage, magnetic disk storage or other magnetic storage devices, flash memory devices (e.g., solid-state memory devices), or any other available medium accessible by a general-purpose or special-purpose computer, which may be used to execute or store desired program code in the form of computer-executable instructions or data structures stored therein. The above combinations may be included within the scope of computer-decipherable storage mediums. Computer-executable instructions may include, for example, instructions or data arranged to execute an operation or set of operations on the processor 66.

[0042] In some embodiments, one or more physician monitoring devices 73 may be connected to a computing system 64 via a network 78. In these and other embodiments, the network 78 may comprise a wired or wireless network and may have any preferred structure, such as a star configuration, a token ring configuration, or other configurations. Furthermore, in some embodiments, the network 78 may comprise an Ethernet network, a local area network (LAN), a wide area network (WAN) (e.g., the Internet), and / or other interconnection data path access to multiple devices that may communicate. In some embodiments, the network 78 may be connected to or comprise a portion of a communication network that can enable data communication in a number of different communication protocols. In some embodiments, the physician monitoring device 73 may comprise or correspond to any of the physician monitoring devices 46 described with respect to Figure 2.

[0043] In some embodiments, network 78 may include a Bluetooth® communication network and / or a cellular communication network for data transmission and reception, including via Short Message Service (SMS), Multimedia Message Service (MMS), Hypertext Transfer Protocol (HTTP), Direct Data Connection, Wireless Application Protocol (WAP), e-mail, etc. Network 78 may also enable communication via standards-based protocols such as Smart Energy Profile (SEP), Echonet Lite, OpenADR, or another preferred protocol (e.g., Wireless Fidelity (Wi-Fi), ZigBee, HomePlug Green, etc.).

[0044] In some embodiments, the communication unit 72 may be configured to transmit and receive data to and from the physician monitoring device 73 via the network 78. In some embodiments, the communication unit 72 may be configured to transmit and receive data from the display screen 80 and / or the electronic health record 82. In some embodiments, the display screen 80 may comprise or correspond to the display screen 50 described with respect to Figure 2A or 2B. In some embodiments, the electronic health record 82 may comprise or correspond to the electronic health record 52 of Figure 2B. In some embodiments, the cleaning module 76 may be configured to transmit and receive data via the communication unit 72.

[0045] In some embodiments, the communication unit 72 may include ports for direct physical connection to the network 78 and / or another communication channel. For example, the communication unit 72 may include a Universal Serial Bus (USB) port, an SD port, a Category 5 cable (CAT-5) port, or a similar port for wired communication with another device. In some embodiments, the communication unit 72 may include a wireless transceiver for exchanging data with the physician monitoring device 46 or another communication channel using one or more wireless communication methods, including IEEE 802.11, IEEE 802.16, BLUETOOTH®, or another preferred wireless communication method.

[0046] In some embodiments, the communication unit 72 may include a cellular communication transceiver for sending and receiving data over cellular communication, including SMS, MMS, HTTP, direct data connection, WAP, e-mail, or another preferred type of electronic transmission. The communication unit 72 may also provide another conventional connection to the network 78 for the delivery of files or media using standard network protocols, including Communication Control Protocol / Internet Protocol (TCP / IP), HTTP, HTTP Secure (HTTPS), and Simple Mail Transfer Protocol (SMTP).

[0047] Specific examples of how the cleaning module 76 may manage the cleaning of the catheter assembly or monitor the flow through the catheter assembly are now provided. In some embodiments, the cleaning module 76 may be configured to start a timer in response to one or more acoustic sensors 84 detecting that a clamp is closed. In some embodiments, the acoustic sensors 84 may comprise or correspond to the acoustic sensors 42 described in relation to Figures 1 or 4. In some embodiments, in response to the timer 86 reaching a predetermined length of time, the cleaning module 76 may be configured to generate one or more alerts at the clamp and / or send an alert signal on the network 78 to a physician monitoring device 73, which may provide one or more alerts. In some embodiments, the alerts may indicate any alerts as described in relation to Figures 1 and 2. In some embodiments, the alerts may indicate to the physician that a time has been reached or is approaching that is medically recommended for cleaning the catheter assembly.

[0048] In some embodiments, in response to one or more acoustic sensors 84 detecting that the clamp 63 is closed, the cleaning module 76 may be positioned to display in the patient's electronic health record 88. In some embodiments, the electronic health record 88 may be stored and / or displayed on a physician monitoring device 73. In some embodiments, the electronic health record 88 may comprise or correspond to the electronic health record 52 described in relation to Figure 2.

[0049] In some embodiments, the cleaning module 76 may be configured to stop and / or reset the timer 86 in response to one or more acoustic sensors 84 detecting that the clamp 63 is open or open for another predetermined length of time. In some embodiments, the cleaning module 76 may be configured to stop the timer 86 only after the clamp 63 has been open for another predetermined length of time to prevent the clamp 63 from opening if sufficient cleaning has not been performed.

[0050] In some embodiments, the cleaning module 76 may be configured to stop an alert on the clamp 63 or provide a different alert on the clamp in response to one or more acoustic sensors 84 detecting that the clamp is open for a predetermined length of time on the other. Furthermore, or alternatively, in some embodiments, the cleaning module 76 may be configured to send another alert signal on the network 78 in response to one or more acoustic sensors 88 detecting that the clamp is open for a predetermined length of time on the other, in response to the physician monitoring device 73 stopping an alert or providing a different alert. In some embodiments, the cleaning module 76 may be configured to provide another indication in the patient's electronic health record 88 in response to one or more acoustic sensors 88 detecting that the clamp 63 is open for a predetermined length of time on the other.

[0051] In some embodiments, the irrigation module 76 may be configured to stop or reset the timer 86 in response to one or more acoustic sensors detecting the flow of fluid through the extension tube of the catheter assembly. In some embodiments, the external server may comprise one or more components of the computing system 64. For example, the external server may comprise a processor 66. In some embodiments, the external server may be connected to the clamp 63 and / or physician monitoring device 73 via network 78 or another network. Modifications, additions, or deletions may be made to the FM system 62 without departing from the scope of this disclosure.

[0052] Referring now to Figures 4A-4B, the clamp 90 is shown according to several embodiments. In some embodiments, the clamp 90 may comprise or correspond to the ramp 36 described in relation to Figure 1. In some embodiments, the clamp 90 may be replaced by the clamp 36 in Figure 1. In some embodiments, the extension tube 34 of the catheter system in Figure 1 may extend through the clamp 90.

[0053] In some embodiments, the clamp 90 does not need to have a tightening clamp. In some embodiments, the clamp 90 may be positioned to tighten the extension tube 34 or to stop the flow of fluid through the extension tube 34. In some embodiments, when the clamp 90 is in the closed position, the clamp 90 may surround the extension tube 34.

[0054] In some embodiments, the extension tube 34 may be equipped with a clamp 90 and / or a tightening clamp. In some embodiments, the clamp 90 may be equipped with any suitable extension tube. In some embodiments, the clamp 90 may be positioned on the IV line and may extend between the IV bag and the catheter assembly 16. In some embodiments, the peripherally inserted central catheter ("PICC") assembly may be equipped with a pigtail extension tube, and the special clamp 90 may be connected to one or more pigtail extension tubes.

[0055] In some embodiments, the clamp 90 may be opened via one or more hinges 92 or another preferred mechanism. In some embodiments, the clamp 90 may include a channel 94 extending through it. In some embodiments, the outer diameter of the extension tube 34 may be slightly smaller than the diameter of the channel 94. In some embodiments, the extension tube 34 may be in contact with the channel 94.

[0056] In some embodiments, the portion of the acoustic sensor 42 may vary. In some embodiments, the acoustic sensor 42 may be embedded in the channel 94. In some embodiments, for example, as shown in Figure 4B, the acoustic sensor 42 may be in contact with the extension tube 34 when the clamp 90 is in the closed position. In some embodiments, when the clamp 89 is in the closed position, the acoustic sensor 42 may be spaced apart from the extension tube 34.

[0057] In some embodiments, the first acoustic sensor 42a and the second acoustic sensor 42b may provide robotic determination of whether fluid is flowing through the extension tube 34 and whether the clamp 36 is open or closed. In some embodiments, the first acoustic sensor 42a may be positioned distal to the second acoustic sensor 42b. In some embodiments, the direction of fluid flow in the extension tube 34 may be determined in response to the first acoustic sensor 42a detecting fluid flow through the extension tube 34, either before or after the other acoustic sensor 42b detecting fluid flow through the extension tube 34. In some embodiments, the direction of fluid flow may be determined to be proximal in response to the first acoustic sensor 42a detecting fluid flow through the extension tube 34 before the second acoustic sensor 42b. In some embodiments, the direction of fluid flow may be determined to be distal in response to the second acoustic sensor 42b detecting fluid flow through the extension tube 34 before the first acoustic sensor 42a.

[0058] In some embodiments, the acoustic sensor 42 may be electrically connected to the circuit board 43 and the charger 44. In some embodiments, the positions of the circuit board 43 and the charger 44 may vary. In some embodiments, the circuit board 43 may include a transmitting unit.

[0059] Referring now to Figure 5A, an exemplary waveform 98 generated by an acoustic sensor is shown according to several embodiments. In some embodiments, the flow portion 100 of the waveform 98 may represent the flow of fluid through an extension tube, such as an extension tube 34, as described with respect to Figures 1 and 2. In some embodiments, the non-flow portion 102 of the waveform 98 may represent the absence of fluid flow through the extension tube 34 or the closing of a clamp.

[0060] In some embodiments, the fluid flow through the extension tube may be determined based on the presence of a flow portion 100, which may have one or more of the following distinctive signs: a characteristic frequency, a characteristic amplitude, a length, and a characteristic sound energy. Further details, in some embodiments, the distinctive signs of the flow portion 100 may include a characteristic frequency such as a maximum or peak frequency, multiple occurrences of the maximum or peak frequency over a period, or an average frequency over a period. Furthermore, or alternatively, in some embodiments, the distinctive signs of the flow portion 100 may include a characteristic amplitude such as a maximum or peak amplitude, multiple occurrences of the maximum or peak amplitude over a period, or an average amplitude over a period. In some embodiments, one or more of the following distinct signs of the flow portion 100 may be greater than or equal to one or more thresholds: a characteristic frequency, a characteristic amplitude, and a characteristic sound energy. In some embodiments, the amplitude or frequency may be leaky, such as a person speaking or an alert, and may not be related to the fluid flow.

[0061] In some embodiments, the threshold depends on one or more of the following: the wall thickness of the extension tube, the distance from the extension tube to the acoustic sensor, the material from which the extension tube is constructed, the gauge size of the extension tube, and the catheter, such as catheter 20 shown with respect to Figure 1. Further details are available, in some embodiments, the threshold may vary depending on the characteristics of the extension tube, such as the wall thickness of the extension tube, the material from which the extension tube is constructed, and the gauge size of the extension tube. In some embodiments, the threshold may be measured before inserting the catheter into the patient by flushing the catheter with the fluid so that the fluid flows through the extension tube of the catheter system and is detected by the acoustic sensor.

[0062] In some embodiments, a lack of fluid flow through the extension tube may be determined based on the presence of a non-flow portion 102, which may have a distinct sign including one or more of the following: another characteristic frequency, another characteristic amplitude, length, and another characteristic sound energy. Further details, in some embodiments, the distinct sign of the non-flow portion 102 may include, for example, a maximum or peak frequency, multiple occurrences of the maximum or peak frequency over a period, or an average frequency over a period. Furthermore, or alternatively, in some embodiments, the distinct sign of the non-flow portion 102 may include, for example, a maximum or peak amplitude, multiple occurrences of the maximum or peak amplitude over a period, or an average amplitude over a period. In some embodiments, one or more of the following distinct signs of the non-flow portion 102 may be smaller than one or more thresholds: another characteristic frequency, another characteristic amplitude, and another characteristic sound energy. In some embodiments, the amplitude or frequency may leak, for example, a person speaking or an alert, and may not be related to fluid flow.

[0063] In some embodiments, the fluid flow through the extension tube may be determined in response to acoustic sensors detecting one or more of the following: a specific frequency greater than a certain threshold, a specific amplitude greater than a certain threshold, or a specific sound energy greater than a certain threshold. In some embodiments, the specific frequency may comprise a maximum or peak frequency, multiple occurrences of the maximum or peak frequency over a period, or an average frequency over a period. In some embodiments, the specific amplitude may comprise a maximum amplitude, multiple occurrences of the maximum or peak amplitude over a period, or an average amplitude over a period. In some embodiments, the specific sound energy may be based on the sum of the integrated potential and kinetic energy densities on the volume in question.

[0064] In some embodiments, it may be determined that no fluid is flowing through the extension tube in response to acoustic sensors detecting one or more of the following: a specific frequency less than a certain threshold, a specific amplitude less than a certain threshold, or a specific sound energy less than a certain threshold. In some embodiments, the specific frequency may include a special frequency such as a maximum or peak frequency, multiple occurrences of the maximum or peak frequency over a period, or an average frequency over a period. In some embodiments, the special amplitude may include a maximum or peak amplitude, multiple occurrences of the maximum or peak amplitude over a period, or an average amplitude over a period.

[0065] As shown in Figure 5A, in some embodiments, the maximum amplitude of the non-flow portion 102 may be between approximately -18 dB and approximately -24 dB, and this may be used as a threshold. In these and other embodiments, the maximum amplitude of the flow portion 100 may be higher, for example, approximately 0 dB, approximately -2 dB, or approximately -5 dB, and this may be used as a threshold. In some embodiments, the flow portion 100 may correspond to frequencies between approximately 80 and approximately 200 Hz, and this may be used as a threshold. In some embodiments, the non-flow portion 102 may correspond to frequencies between approximately 40 and approximately 80 Hz, and this may be used as a threshold. In some embodiments, the waveform 98 in Figures 5A-5B may correspond to a standard plastic extension tube, such as a Becton Dickinson NEXIVA® closed IV catheter system or a similar catheter system, with an acoustic sensor positioned near the proximal end of the extension tube or close to the proximal end. It is understood that a variety of scales may be used, including seconds, milliseconds, or other units of time on the x-axis, and decibels, or other units of time on the y-axis.

[0066] Referring now to Figure 5B, in some embodiments, an exemplary waveform 104 generated by a first acoustic sensor and an exemplary waveform 106 generated by a second acoustic sensor are shown. In some embodiments, the first acoustic sensor may be positioned distal to or proximal to the second acoustic sensor.

[0067] In some embodiments, the direction of fluid flow in an extension tube, such as extension tube 34, as described with respect to Figures 1 and 2, may be determined in response to a first acoustic sensor detecting fluid flow through the extension tube, either before or after another acoustic sensor detecting fluid flow through the extension tube. The first acoustic sensor may detect fluid flow through the extension tube, as shown in Figure 5B, before the second acoustic sensor detecting fluid flow through the extension tube, as indicated by the flow portion 100 of waveform 104 occurring earlier than the flow portion 100 of waveform 106. In some embodiments, due to a time delay, the flow portion 100 of waveform 104 may be spaced apart from the flow portion 100 of waveform 106.

[0068] In some embodiments, in response to a first acoustic sensor located distal to a second acoustic sensor, the time delay 108 shown in Figure 5B may indicate that fluid flows proximal through the extension tube.

[0069] Again, it is understood that a variety of scales may be used, including seconds, milliseconds, or other time units on the x-axis, and decibels, or other time units on the y-axis. In some embodiments, the time delay 108 may be less than a few milliseconds or less than a few microseconds. In some embodiments, the time delay 108 may be based on the distance between the first acoustic sensor and the second acoustic sensor, and these distances may vary. In some embodiments, the first acoustic sensor and / or the second acoustic sensor may detect the distance or time delay between one or more peaks of waveform 104 and waveform 106, which may indicate that fluid is flowing through the extension tube in a particular direction. For example, if the first acoustic sensor detects one or more peaks before the second acoustic sensor detects one or more peaks, it may be determined that the fluid is flowing in the proximal direction.

[0070] All examples and conditional language described herein are intended for educational purposes to assist the reader in understanding the concepts to which the inventors have contributed to the advancement of the invention and the art, and should be construed as not limiting to such specifically described examples and conditions. Although embodiments of the invention have been described in detail, it should be understood that various modifications, substitutions, and alternatives can be made herein without departing from the spirit and scope of the invention.

Claims

1. A clamping clamp for an extension tube connected to a catheter adapter, The aforementioned clamping clamp is An arm having a protrusion configured to contact and tighten the extension tube, The clamping surface is configured to contact the extension tube when the clamp is in the open and closed positions. A first microphone embedded in the clamp and positioned on the clamping surface, A second microphone embedded in the clamp and positioned on the clamping surface, Lights, and also, Equipped with a computer system, The first microphone is positioned distal to the second microphone. The aforementioned computer system, The system detects from the signals received by the first and second microphones that no liquid is flowing through the extension tube. In response to the detection that no liquid is flowing through the extension tube, a timer is started for a predetermined length of time. In response to the elapsed time of the predetermined length, the light on the clamp provides an indication that the liquid is no longer flowing through the extension tube. The flow of liquid distally within the extension tube is detected from the signals received from the first and second microphones. A clamping clamp configured to turn off the light it displays in response to detection that a liquid is flowing distally through an extension tube.

2. The clamping clamp according to claim 1, wherein the light is embedded in the arm.

3. The clamping clamp according to claim 1, wherein the computer system is configured such that, in response to the elapsed time of a second length, the light provides a pre-indication on the clamping clamp, the second length of time being shorter than the predetermined length of time.

4. The clamping clamp according to claim 3, wherein the pre-indication and the indication are in different colors.

5. The clamping clamp according to claim 3, wherein the pre-indication and the indication have different flashing speeds or patterns.

6. The computer system detects that the liquid is not flowing through the extension tube and The clamping clamp according to claim 1, configured to transmit information indicating the detection of a liquid flowing distally within an extension tube.

7. The clamping clamp according to claim 6, wherein the information includes time in each direction.

8. The clamping clamp according to claim 1, wherein the computer system detects that liquid is flowing distally within the extension tube from signals received from the first microphone and the second microphone by detecting that the second microphone has generated a signal indicating liquid flow before the first microphone has generated a signal indicating liquid flow.

9. The clamping clamp according to claim 8, wherein the computer system detects that individual signals have an amplitude greater than a threshold to identify a signal indicating liquid flow.

10. The clamping clamp according to claim 9, wherein the amplitude is an average amplitude.

11. The clamping clamp according to claim 9, wherein the threshold is based on the thickness of the extension tube.

12. The clamping clamp according to claim 1, wherein the first microphone and the second microphone are configured to be in contact with the extension tube.

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